JP4590912B2 - Aseptic closure device - Google Patents

Aseptic closure device Download PDF

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JP4590912B2
JP4590912B2 JP2004121692A JP2004121692A JP4590912B2 JP 4590912 B2 JP4590912 B2 JP 4590912B2 JP 2004121692 A JP2004121692 A JP 2004121692A JP 2004121692 A JP2004121692 A JP 2004121692A JP 4590912 B2 JP4590912 B2 JP 4590912B2
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seal member
opening
shutter
annular seal
partition wall
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JP2005304530A (en
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登 西村
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Shibuya Corp
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Shibuya Machinery Co Ltd
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Priority to JP2004121692A priority Critical patent/JP4590912B2/en
Priority to US11/101,203 priority patent/US20050232807A1/en
Priority to EP05008173A priority patent/EP1588719A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26—Accessories or devices or components used for biocidal treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04—Heat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/12—Apparatus for isolating biocidal substances from the environment
    • A61L2202/121—Sealings, e.g. doors, covers, valves, sluices

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Description

本発明は、無菌状態で使用される複数の空間を区画する仕切壁に形成された開口部を、シャッターによって閉鎖する無菌閉鎖装置に関するものである。   The present invention relates to an aseptic closure device that closes an opening formed in a partition wall that divides a plurality of spaces used in an aseptic state by a shutter.

例えば、乾燥滅菌機とアイソレータとを隣接して配置し、これら両空間の間を仕切る仕切壁に開口部を形成して、乾燥滅菌機で滅菌処理した容器等の物品を、前記開口部を通ってアイソレータに搬入し次の処理を行うようにした滅菌処理システムが従来から知られている。   For example, a dry sterilizer and an isolator are arranged adjacent to each other, and an opening is formed in a partition wall that divides the two spaces, and an article such as a container sterilized by a dry sterilizer passes through the opening. Conventionally, a sterilization system that is carried into an isolator and performs the following processing is known.

前記のような二つの空間を仕切る仕切壁に形成されている開口部は、シャッターで開閉できるようにしてあり、空間の内部を滅菌する際には、シャッターに取り付けたパッキン（シール部材）を仕切壁の開口部の周囲に押しつけて密封している。ところが、パッキンとシャッターとの接触部分は、両側の空間のどちらを滅菌する場合でも、常に仕切壁の壁面に密着しているので、滅菌ガス等の滅菌剤に接触することがなく、また、パッキンは乾燥滅菌機の熱風が届きにくく充分に加熱されることがないため、常に滅菌されない部分が残ってしまうことになる。   The opening formed in the partition wall that partitions the two spaces as described above can be opened and closed by a shutter, and when sterilizing the interior of the space, the packing (seal member) attached to the shutter is partitioned. It is sealed by pressing around the wall opening. However, the contact portion between the packing and the shutter is always in close contact with the wall surface of the partition wall regardless of which side of the space is sterilized. Since the hot air of the dry sterilizer is difficult to reach and is not heated sufficiently, a portion that is not sterilized always remains.

そこで本発明の出願人は、開口部の周囲の壁面に取り付けられたパッキンおよびこのパッキンが密着するシャッターも含めてすべての部分を滅菌することができる滅菌装置の発明について出願した（特許文献１参照）。   Therefore, the applicant of the present invention has filed an application for an invention of a sterilization apparatus that can sterilize all parts including a packing attached to a wall surface around an opening and a shutter to which the packing is closely attached (see Patent Document 1). ).

前記特許文献１に記載された滅菌装置は、大容積のアイソレータ内を、開口部を有する仕切壁によって複数の空間に区画し、前記開口部をシャッターおよびシール部材によって開閉するものであり、前記仕切壁の開口部の周囲に、この開口部を囲む環状の第１シール部材を、そして、この第１シール部材の外周側に環状の第２シール部材を設けてある。これらシール部材は、それぞれ、圧縮エアを導入し膨張させることにより前記シャッターに密着させることができる。   The sterilization apparatus described in Patent Document 1 divides a large-volume isolator into a plurality of spaces by a partition wall having an opening, and opens and closes the opening by a shutter and a seal member. An annular first seal member surrounding the opening is provided around the opening of the wall, and an annular second seal member is provided on the outer peripheral side of the first seal member. Each of these seal members can be brought into close contact with the shutter by introducing and expanding compressed air.

前記滅菌装置では、仕切壁によって区画された両側の空間のうち一方の空間を滅菌する場合には、一方のシール部材を膨張させてシャッターに密着させ、他方の膨張していないシール部材が露出している側の空間を滅菌する。また、他方の空間を滅菌する場合には、前記と別のシール部材を膨張させてシャッターに密着させ、膨張していないシール部材が露出している側の空間を滅菌する。このようにして両側の空間を順次滅菌すると、二つのシール部材も滅菌される。
特開２００２−６５８２０号公報（第２−３頁、図５） In the sterilization apparatus, when sterilizing one of the spaces on both sides defined by the partition wall, one seal member is inflated and brought into close contact with the shutter, and the other non-expanded seal member is exposed. Sterilize the side space. When the other space is sterilized, a seal member different from the above is expanded and brought into close contact with the shutter, and the space on the side where the unexpanded seal member is exposed is sterilized. When the spaces on both sides are sequentially sterilized in this way, the two sealing members are also sterilized.
JP 2002-65820 A (page 2-3, FIG. 5)

前記特許文献１に記載された発明の滅菌装置は、環状のシール部材を二重に配置しなければならず、また、工程を二回に分けて滅菌する必要があるため、構造が複雑でコスト高であり、また、作業時間がかかるという問題点があった。   In the sterilization apparatus of the invention described in Patent Document 1, the annular seal member must be doubled, and it is necessary to sterilize the process in two steps. There is a problem that it is expensive and takes a long time.

本発明は、複数の無菌空間を仕切る仕切壁に形成された開口部よりも大きい面積を有するシャッターと、このシャッターを、前記開口部を覆う位置と開放する位置とに移動させる移動手段と、前記シャッターまたは前記仕切壁の開口部の周囲のいずれか一方に設けられ、膨張してシャッターと仕切壁の間を密封する環状シール部材とを備え、前記開口部を閉鎖する無菌閉鎖装置において、前記シャッターまたは開口部の周囲に、環状シール部材を嵌め込むための装着溝を形成し、この装着溝の内面を加熱して環状シール部材を滅菌するヒーターと、前記環状シール部材が膨張して密着する開口部周囲の壁面またはシャッターの表面を加熱して、密着した環状シール部材を滅菌するヒーターを設け、前記環状シール部材は、膨張した状態でそれぞれのヒーターの熱により滅菌されることを特徴とするものである。 The present invention includes a shutter having an area larger than an opening formed in a partition wall that partitions a plurality of sterile spaces, a moving unit that moves the shutter to a position that covers the opening and a position that opens. either provided on one circumference of the opening of the shutter or the partition wall, expanded and an annular seal member for sealing between the shutter and the partition wall, in a sterile closure device for closing said opening, the shutter Alternatively, a mounting groove for fitting the annular seal member is formed around the opening, a heater for heating the inner surface of the mounting groove to sterilize the annular seal member, and an opening in which the annular seal member expands and closely contacts parts by heating the surrounding wall or surface of the shutter, a heater for sterilizing the annular seal member in close contact provided, the annular sealing member, it inflated condition It is characterized in that the sterilized by Les heater heat.

本発明の無菌閉鎖装置は、単一の環状シール部材を装着するだけで、このシール部材と、シール部材が密着するシャッターや仕切壁等の滅菌を行うことが可能であり、構造が簡単で、滅菌作業も容易である。   The aseptic closure device of the present invention can sterilize the seal member and the shutter, partition wall, etc. with which the seal member is in close contact only by mounting a single annular seal member, and has a simple structure, Sterilization is easy.

シャッターかこのシャッターによって覆われる開口部の周囲のいずれか一方に設けた環状シール部材が、膨張した際に密着する相手側の開口部周囲またはシャッターの表面に、ヒーターを設けて加熱するという簡単な構成で、環状シール部材も含めて無菌空間内の全てを滅菌するという目的を達成することができる。   The annular seal member provided on either the shutter or the periphery of the opening covered by the shutter is simply provided with a heater around the other opening or the surface of the shutter that is in close contact when expanded. With the configuration, the object of sterilizing the entire aseptic space including the annular seal member can be achieved.

以下、図面に示す実施例により本発明を説明する。図１は、本発明の一実施例にかかる無菌閉鎖装置を示すもので、無菌状態で使用される複数の空間（乾燥滅菌機２およびアイソレータ４）の間を仕切る仕切壁６に形成された開口部６ａを無菌閉鎖装置（全体として符号１で示す）によって密封した状態を示す縦断面図、図２は前記無菌閉鎖装置１を構成する開口部６ａの周囲とシャッター８を示す正面図、図３は図１の要部の拡大断面図である。   Hereinafter, the present invention will be described with reference to embodiments shown in the drawings. FIG. 1 shows an aseptic closure apparatus according to an embodiment of the present invention, and an opening formed in a partition wall 6 that partitions a plurality of spaces (dry sterilizer 2 and isolator 4) used in an aseptic state. FIG. 2 is a longitudinal sectional view showing a state in which the part 6a is sealed by a sterile closure device (indicated by reference numeral 1 as a whole), FIG. FIG. 2 is an enlarged cross-sectional view of a main part of FIG.

この実施例では、上流側（図１の左側）にバイアルびん等を乾燥滅菌する乾燥滅菌機２が、そして、下流側に図示しない充填設備を収容したアイソレータ４が配置され、これらの空間２、４が仕切壁６によって区画されている。   In this embodiment, a dry sterilizer 2 for drying and sterilizing vial bottles and the like is arranged on the upstream side (left side in FIG. 1), and an isolator 4 containing a filling facility (not shown) is arranged on the downstream side. 4 is partitioned by a partition wall 6.

乾燥滅菌機２とアイソレータ４との間を仕切る仕切壁６には、これら両空間２、４を連通してバイアルびん等の容器の受け渡しを行う開口部６ａが形成されている。乾燥滅菌機２内には、前記容器を連続的に搬送する搬送コンベヤ１０が配置されており、この搬送コンベヤ１０で搬送される間に乾燥滅菌された容器が、搬送コンベヤ１０の下流端に設置された渡り板１２を介して前記開口部６ａ側に押し出される。これら容器は、アイソレータ４内に回動可能に設けられ、通常運転時には水平状態になっている可動式の渡り板１４に乗り移った後、固定の渡り板１６を介してアイソレータ２のコンベヤ１８に引き渡され、前記充填設備に搬送される。前記可動式渡り板１４は、水平位置と図１に示す直立した位置とに回動できるようになっており、通常の運転中は水平状態にして、前記乾燥滅菌機２の渡り板１２とアイソレータ４内の固定渡り板１６との間を接続し、以下に説明するシャッター８で開口部６ａを閉塞するときには、図１に示すように直立した状態にして、シャッター８との干渉を避けるようにしている。   The partition wall 6 that partitions between the dry sterilizer 2 and the isolator 4 is formed with an opening 6a that communicates the spaces 2 and 4 and transfers containers such as vials. In the dry sterilizer 2, a transport conveyor 10 for continuously transporting the containers is disposed, and a container sterilized while being transported by the transport conveyor 10 is installed at the downstream end of the transport conveyor 10. It pushes out to the said opening part 6a side via the bridge plate 12 which was made. These containers are provided in the isolator 4 so as to be rotatable, and after being transferred to the movable transition plate 14 that is in a horizontal state during normal operation, the containers are transferred to the conveyor 18 of the isolator 2 through the fixed transition plate 16. It is conveyed to the filling facility. The movable transition plate 14 can be rotated between a horizontal position and an upright position shown in FIG. 1, and is kept in a horizontal state during normal operation so that the transition plate 12 and the isolator 4 in the dry sterilizer 2 are in a horizontal state. When the opening 6a is closed with a shutter 8 described below, the stationary transition plate 16 is connected to the stationary bridge plate 16 so as to avoid interference with the shutter 8 as shown in FIG.

前記乾燥滅菌機２およびアイソレータ４は、それぞれ内部を滅菌する必要があり、滅菌時には、容器の受け渡しを行う開口部６ａを密閉できるように、本発明の一実施例に係る無菌閉鎖装置１が設けられている。この無菌閉鎖装置１は、仕切壁６のアイソレータ４側の面に上方を向けて垂直に固定された、シャッター８の移動手段としてのエアシリンダ２０と、このエアシリンダ２０のピストンロッド２０ａに固定されて、前記仕切壁６の開口部６ａに対向する位置と、開口部６ａよりも下方の位置との間で昇降されるシャッター８と、このシャッター８に取り付けられた環状のシール部材２２とを備えている。前記シャッター８は、仕切壁６の開口部６ａに対向する位置に移動されたときには開口部６ａ全面を覆うことができるように、開口部６ａよりも大きい面積を有している。なお、エアシリンダ２０の上端とピストンロッド２０ａの先端との間に、エアシリンダ２０の摺動部を覆うじゃばら２４が装着されている。   The dry sterilizer 2 and the isolator 4 each need to be sterilized, and at the time of sterilization, the aseptic closure device 1 according to one embodiment of the present invention is provided so that the opening 6a for delivering the container can be sealed. It has been. The aseptic closing device 1 is fixed to an air cylinder 20 as a moving means of the shutter 8 fixed vertically upward on the surface of the partition wall 6 on the side of the isolator 4 and a piston rod 20a of the air cylinder 20. The shutter 8 is moved up and down between a position facing the opening 6 a of the partition wall 6 and a position below the opening 6 a, and an annular seal member 22 attached to the shutter 8. ing. The shutter 8 has a larger area than the opening 6a so that the entire surface of the opening 6a can be covered when moved to a position facing the opening 6a of the partition wall 6. A bellows 24 that covers the sliding portion of the air cylinder 20 is mounted between the upper end of the air cylinder 20 and the tip of the piston rod 20a.

次に、仕切壁６の開口部６ａと、この開口部６ａを密封するシャッター８の構造について、図２および図３により説明する。開口部６ａは、両端部が円弧状をした横長形状をしており、仕切壁６のこの開口部６ａの周囲を囲む壁面に、ヒーター２４が取り付けられている。このヒーター２４は電熱線からなっている。   Next, the structure of the opening 6a of the partition wall 6 and the shutter 8 that seals the opening 6a will be described with reference to FIGS. The opening 6a has a horizontally long shape with arcs at both ends, and a heater 24 is attached to the wall surface of the partition wall 6 surrounding the opening 6a. The heater 24 is composed of a heating wire.

一方、シャッター８の開口部６ａ側の面８ａには、開口部６ａの面積とほぼ一致するサイズのヒーター２６（図１参照）が埋め込まれている。また、シャッター８の外周部には、前記開口部６ａ側に設けられたヒーター２４の形状とほぼ合致する形状の断面コ字状の溝（シール部材装着溝）８ｂが形成されている。このコ字状のシール部材装着溝８ｂの開放されている側が前記仕切壁６側を向いており、この装着溝８ｂ内に環状のシール部材２２が取り付けられて前記開口部６ａの周囲のヒータ２４と向かい合っている。この環状のシール部材２２は、底面２２ｂがコ字状のシール部材装着溝８ｂの底面８ｂａに接着されており、その他の部分はどこにも固定されず自由に変形できる状態になっている。   On the other hand, a heater 26 (see FIG. 1) having a size substantially equal to the area of the opening 6a is embedded in the surface 8a of the shutter 8 on the opening 6a side. In addition, a groove (seal member mounting groove) 8b having a U-shaped cross section substantially matching the shape of the heater 24 provided on the opening 6a side is formed on the outer peripheral portion of the shutter 8. The open side of the U-shaped seal member mounting groove 8b faces the partition wall 6 side, and an annular seal member 22 is mounted in the mounting groove 8b, and the heater 24 around the opening 6a. Facing each other. The annular seal member 22 has a bottom surface 22b bonded to the bottom surface 8ba of the U-shaped seal member mounting groove 8b, and other portions are not fixed anywhere and can be freely deformed.

この環状のシール部材２２は、例えばシリコーンゴム等の膨張収縮可能な素材からなっており、内部が図示しないエア供給源に接続されている。このエア供給源から環状のシール部材２２の内部に圧縮エアを導入することにより膨張させることができる。図１に示す環状シール部材２２は、内部に圧縮エアを導入して膨張させた状態を示しており、膨張した状態では、先端面２２ａがシャッター８の前記シール部材装着溝８ｂから外部に突出して、仕切壁６の開口部６ａの周囲に取り付けたヒーター２４の表面に密着している。このときには、環状のシール部材２２の両側部２２ｃ、２２ｃは、コ字状のシール部材装着溝８ｂの両側壁８ｂｂ、８ｂｂに密着している。また、図３に示す環状のシール部材２２は、内部からエアを排出した状態を示し、先端面２２ａは後退して開口部６ａ側のヒーター２４から離れて、前記シール部材装着溝８ｂの内部に収容されている。そして、両側面２２ｃ、２２ｃもコ字状のシール部材装着溝８ｂの両側壁８ｂｂ、８ｂｂから離れた状態になっている。   The annular seal member 22 is made of a material capable of expanding and contracting, such as silicone rubber, and the inside is connected to an air supply source (not shown). The air supply source can be expanded by introducing compressed air into the annular seal member 22. The annular seal member 22 shown in FIG. 1 shows a state in which compressed air is introduced and expanded therein, and in the expanded state, the front end surface 22a protrudes from the seal member mounting groove 8b of the shutter 8 to the outside. The heater 24 attached around the opening 6a of the partition wall 6 is in close contact with the surface. At this time, both side portions 22c and 22c of the annular seal member 22 are in close contact with both side walls 8bb and 8bb of the U-shaped seal member mounting groove 8b. Further, the annular seal member 22 shown in FIG. 3 shows a state in which air is discharged from the inside, and the front end surface 22a is retracted and separated from the heater 24 on the opening 6a side to enter the inside of the seal member mounting groove 8b. Contained. Both side surfaces 22c and 22c are also separated from both side walls 8bb and 8bb of the U-shaped seal member mounting groove 8b.

シャッター８の内部の、環状のシール部材２２を収容しているコ字状の装着溝８ｂの底部８ｂａおよび両側部８ｂｂ、８ｂｂを囲む位置に、電熱線からなるヒーター２８が埋め込まれている。   A heater 28 made of a heating wire is embedded in a position surrounding the bottom 8ba and both side portions 8bb and 8bb of the U-shaped mounting groove 8b accommodating the annular seal member 22 inside the shutter 8.

以上の構成に係る無菌閉鎖装置１の作動について説明する。バイアル等の容器に無菌状態で充填を行う場合には、エアシリンダ２０の作動によってシャッター８を下降させることにより、乾燥滅菌機２とアイソレータ４との間を仕切る仕切壁６に形成されている開口部６ａを開放するとともに、アイソレータ２側の可動式渡り板１４を倒して水平にし、乾燥滅菌機２内の固定渡り板１２とアイソレータ２内の固定渡り板１６とを連続した状態にする。   The operation of the aseptic closure device 1 according to the above configuration will be described. When filling a container such as a vial in aseptic condition, the opening formed in the partition wall 6 that partitions the dry sterilizer 2 and the isolator 4 by lowering the shutter 8 by operating the air cylinder 20. While opening the part 6a, the movable transition board 14 by the side of the isolator 2 is tilted and leveled, and the fixed transition board 12 in the dry sterilizer 2 and the fixed transition board 16 in the isolator 2 are made continuous.

この状態で、乾燥滅菌機２内に容器を導入し、搬送コンベヤ１０によって連続的に搬送している間に乾燥滅菌を行う。乾燥滅菌が終了した容器は、搬送コンベヤ１０上から後続の容器に押されて順次渡り板１２上に乗り移り、さらに、アイソレータ４側の可動式渡り板１４に乗り移るとともに仕切壁６の開口部６ａを通り抜け、固定渡り板１６上に移った後アイソレータ４のコンベヤ１８上に乗せられ、図示しない充填設備に送られて充填が行われる。   In this state, a container is introduced into the dry sterilizer 2 and dry sterilization is performed while the container is continuously conveyed by the conveyor 10. The container after the dry sterilization is pushed by the subsequent container from the transport conveyor 10 and sequentially moves onto the transition board 12, and further onto the movable transition board 14 on the isolator 4 side and through the opening 6a of the partition wall 6, After moving onto the fixed crossing plate 16, it is placed on the conveyor 18 of the isolator 4 and sent to a filling facility (not shown) for filling.

乾燥滅菌機２およびアイソレータ４内の滅菌を行う場合には、先ず、アイソレータ４内の可動式渡り板１４を跳ね上げて直立状態にした後、エアシリンダ２０によってシャッター８を上昇させ、仕切壁６の開口部６ａと向かい合う状態にする。エア供給源から圧縮エアを環状シール部材２２内に導入すると、環状シール部材２２が膨張して、その先端部２２ａがシール部材装着溝８ｂの外部に突出して、開口部６ａの周囲の壁面に取り付けられているヒーター２４の表面に押し付けられる。また、環状シール部材２２の両側面２２ｃ、２２ｃはコ字状のシール部材装着溝８ｂの両側壁８ｂｂ、８ｂｂに密着する。   When performing sterilization in the dry sterilizer 2 and the isolator 4, first, the movable bridge plate 14 in the isolator 4 is flipped up and brought into an upright state, and then the shutter 8 is raised by the air cylinder 20, and the partition wall 6 It is set to the state facing the opening 6a. When compressed air is introduced into the annular seal member 22 from the air supply source, the annular seal member 22 expands, and its tip 22a protrudes outside the seal member mounting groove 8b and is attached to the wall surface around the opening 6a. Pressed against the surface of the heater 24. Further, both side surfaces 22c, 22c of the annular seal member 22 are in close contact with both side walls 8bb, 8bb of the U-shaped seal member mounting groove 8b.

乾燥滅菌機２とアイソレータ４との間の仕切壁６に形成された開口部６ａをシャッター８とこのシャッター８に取り付けられている環状のシール部材２２によって密封した後、これら乾燥滅菌機２とアイソレータ４とをそれぞれ滅菌する。乾燥滅菌機２内は、熱風で内部を滅菌する。また、アイソレータ４内は過酸化水素蒸気で滅菌する。開口部６ａを覆っているシャッター８の表面８ａは、乾燥滅菌機２内に露出しているが、この表面８ａまでは熱風が届きにくいので、シャッター８の表面８ａ側の内部に埋め込んだヒーター２６によってこの表面８ａを滅菌する。   After the opening 6a formed in the partition wall 6 between the dry sterilizer 2 and the isolator 4 is sealed by the shutter 8 and the annular seal member 22 attached to the shutter 8, the dry sterilizer 2 and the isolator 4 and 4 are sterilized. The inside of the dry sterilizer 2 is sterilized with hot air. The inside of the isolator 4 is sterilized with hydrogen peroxide vapor. The surface 8a of the shutter 8 covering the opening 6a is exposed in the dry sterilizer 2, but hot air does not easily reach the surface 8a, so the heater 26 embedded in the interior of the shutter 8 on the surface 8a side. This surface 8a is sterilized by

また、環状のシール部材２２の先端部２２ａは開口部６ａの周囲の壁面に取り付けたヒーター２４の表面に密着し、環状シール部材２２の両側面２２ｃ、２２ｃはコ字状のシール部材装着溝８ｂの両側壁８ｂｂ、８ｂｂに密着しているので、乾燥滅菌機２側の熱風もアイソレータ４内の過酸化水素蒸気も接触しないため、熱風や過酸化水素によって滅菌することはできないが、それぞれヒーター２４および２８に接触しており、このヒーター２４、２８の熱により滅菌される。   The tip 22a of the annular seal member 22 is in close contact with the surface of the heater 24 attached to the wall surface around the opening 6a, and both side surfaces 22c and 22c of the annular seal member 22 are U-shaped seal member mounting grooves 8b. Since both the hot air on the side of the drying sterilizer 2 and the hydrogen peroxide vapor in the isolator 4 do not come into contact with each other, the sterilization with hot air or hydrogen peroxide cannot be performed. And 28 and is sterilized by the heat of the heaters 24 and 28.

このように一本の環状シール部材２２によって密封した場合でも、この環状シール部材２２を滅菌することができ、従来よりも簡単な構成で、しかも簡単な工程で、乾燥滅菌機２とアイソレータ４の内部の全てを滅菌することが可能である。なお、この実施例では、乾燥滅菌機２とアイソレータ４との間を仕切壁６により区画する構成について説明したが、このような場合に限定されるものではなく、前記特許文献１に記載された構成のように大型のアイソレータを複数の室に区画した場合にも適用することができる。また、環状のシール部材２２をシャッター８側に設けたが、仕切壁６の開口部６ａの周囲の壁面に設けることも可能である。この場合には、仕切壁６側に環状シール部材２２を収容する装着溝を形成し、シャッター８側には、環状シール部材２２の先端が密着する部分にヒーターを設けるようにすればよい。   Thus, even when sealed with the single annular seal member 22, the annular seal member 22 can be sterilized, and the dry sterilizer 2 and the isolator 4 can be sterilized with a simpler structure and simpler process than before. It is possible to sterilize everything inside. In addition, in this Example, although the structure which partitions off between the dry sterilizer 2 and the isolator 4 with the partition wall 6 was demonstrated, it is not limited to such a case, It described in the said patent document 1 The present invention can also be applied when a large isolator is partitioned into a plurality of chambers as in the configuration. Further, although the annular seal member 22 is provided on the shutter 8 side, it can also be provided on the wall surface around the opening 6 a of the partition wall 6. In this case, a mounting groove for accommodating the annular seal member 22 may be formed on the partition wall 6 side, and a heater may be provided on the shutter 8 side where the tip of the annular seal member 22 is in close contact.

開口部を有する仕切壁で区画された無菌空間を密封する無菌閉鎖装置を示す縦断面図である。（実施例１）It is a longitudinal cross-sectional view which shows the aseptic closure apparatus which seals the aseptic space divided by the partition wall which has an opening part. Example 1 前記開口部とシャッターを示す正面図である。It is a front view which shows the said opening part and a shutter. 図１の要部を拡大して示す断面図である。It is sectional drawing which expands and shows the principal part of FIG.

符号の説明Explanation of symbols

２ 無菌空間（乾燥滅菌機）
４ 無菌空間（アイソレータ）
６ 仕切壁
６ａ 開口部
８ シャッター
８ｂ 装着溝（シール部材装着溝）
２０ 移動手段（エアシリンダ）
２２ 環状シール部材
２４ ヒーター
２８ ヒーター 2 Aseptic space (dry sterilizer)
4 Aseptic space (isolator)
6 partition wall 6a opening 8 shutter 8b mounting groove (seal member mounting groove)
20 Moving means (air cylinder)
22 annular seal member 24 heater 28 heater

Claims (1)

複数の無菌空間を仕切る仕切壁に形成された開口部よりも大きい面積を有するシャッターと、このシャッターを、前記開口部を覆う位置と開放する位置とに移動させる移動手段と、前記シャッターまたは前記仕切壁の開口部の周囲のいずれか一方に設けられ、膨張してシャッターと仕切壁の間を密封する環状シール部材とを備え、前記開口部を閉鎖する無菌閉鎖装置において、
前記シャッターまたは開口部の周囲に、環状シール部材を嵌め込むための装着溝を形成し、この装着溝の内面を加熱して環状シール部材を滅菌するヒーターと、前記環状シール部材が膨張して密着する開口部周囲の壁面またはシャッターの表面を加熱して、密着した環状シール部材を滅菌するヒーターを設け、前記環状シール部材は、膨張した状態でそれぞれのヒーターの熱により滅菌されることを特徴とする無菌閉鎖装置。 A shutter having an area larger than an opening formed in a partition wall partitioning a plurality of aseptic spaces; a moving means for moving the shutter between a position covering the opening and a position opening; and the shutter or the partition An aseptic closure device that is provided around any one of the openings of the wall and includes an annular seal member that expands and seals between the shutter and the partition wall, and closes the opening.
A mounting groove for fitting the annular seal member is formed around the shutter or the opening, and a heater for heating the inner surface of the mounting groove to sterilize the annular seal member, and the annular seal member expands and adheres closely. A heater for heating the wall surface around the opening or the surface of the shutter to sterilize the closely attached annular seal member is provided, and the annular seal member is sterilized by the heat of each heater in an expanded state. Aseptic closure device to do.
JP2004121692A 2004-04-16 2004-04-16 Aseptic closure device Expired - Lifetime JP4590912B2 (en)

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JP2004121692A JP4590912B2 (en) 2004-04-16 2004-04-16 Aseptic closure device
US11/101,203 US20050232807A1 (en) 2004-04-16 2005-04-07 Sterile closure apparatus
EP05008173A EP1588719A1 (en) 2004-04-16 2005-04-14 Sterile closure apparatus

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FR2932638B1 (en) * 2008-06-13 2010-08-20 Commissariat Energie Atomique APPARATUS FOR DOCKING AND OPENING FUTS
JP5806232B2 (en) * 2009-12-21 2015-11-10 エーティーエムアイ ビーヴィービーエー Disposable production line
US10858132B2 (en) 2013-10-18 2020-12-08 Pall Life Sciences Belgium Bvba Disposable production line for filling and finishing a product
FR3059905B1 (en) 2016-12-09 2019-05-24 Soluscope MACHINE FOR TREATING A MEDICAL DEVICE
CN112681947B (en) * 2020-12-18 2023-03-10 上海东富龙爱瑞思科技有限公司 Isolator is with double-deck airtight structure mouse hole door

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